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anx_II__cpt_1__cpt_7__text_1

The responsible TAB shall communicate the draft European Assessment Document to the manufacturer, who shall have 15 working days to react thereto. Thereafter, the organisation of TABs shall:

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Source: EUR-Lex (Cellar) · retrieved 2026-10-12 · Text as adopted (Official Journal); later amendments are not incorporated in this text.